Back to resultsTherapeutic Strategy in Advanced Bronchioloalveolar Carcinoma
Primary Purpose
Adenocarcinoma, Bronchiolo-Alveolar
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
erlotinib
paclitaxel + carboplatine
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma, Bronchiolo-Alveolar focused on measuring Adenocarcinoma, Bronchiolo-Alveolar
Eligibility Criteria
Inclusion Criteria:
- CBA histologically proven (or cytologically with pneumonic presentation) PS < 3 signed and written informed consent
Exclusion Criteria:
- visible tumoral lesion in bronchial fibroscopy
Sites / Locations
- Centre Hospitalier - Pneumologie
- APHP - CHU Avicenne - Oncologie Medicale
- Centre F. Baclesse
- CHU - Pneumologie
- CHU Grenoble - pneumologie
- APHP - Saint-Antoine - pneumologie
- APHP - Hopital Tenon - Pneumologie
- Institut de Cancérologie de la Loire
- CHU Lyautey - Pneumologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
16-week Disease Control Rate
Secondary Outcome Measures
Full Information
NCT ID
NCT00384826
First Posted
October 5, 2006
Last Updated
February 12, 2015
Sponsor
Intergroupe Francophone de Cancerologie Thoracique
1. Study Identification
Unique Protocol Identification Number
NCT00384826
Brief Title
Therapeutic Strategy in Advanced Bronchioloalveolar Carcinoma
Official Title
Effect of an Early Therapeutic Permutation on the Tumoral Control of Patients Receiving in First Line a Specific Inhibitor of Tyrosin Kinase of EGFR (Erlotinib) or a Taxan-based Chemotherapy for the Treatment of Not Resecable Adenocarcinoma With Bronchiolo-alveolar.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intergroupe Francophone de Cancerologie Thoracique
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate among patients with untreated advanced ADC-CBA, impact on the disease control rate after 4 months treatment of an early therapeutic permutation with the first month in the absence of stabilization or objective answer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma, Bronchiolo-Alveolar
Keywords
Adenocarcinoma, Bronchiolo-Alveolar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
erlotinib
Intervention Description
Erlotinib 150 mg/day (until progression)
Intervention Type
Drug
Intervention Name(s)
paclitaxel + carboplatine
Intervention Description
Paclitaxel 90 mg/m² D1, D8, D15 (D1=D28, until progression) Carboplatine AUC 6 D1 (D1=D28, 6 cycles)
Primary Outcome Measure Information:
Title
16-week Disease Control Rate
Time Frame
4-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CBA histologically proven (or cytologically with pneumonic presentation) PS < 3 signed and written informed consent
Exclusion Criteria:
visible tumoral lesion in bronchial fibroscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Cadranel
Organizational Affiliation
APHP Hopital Tenon (Pneumologie) - Paris - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier - Pneumologie
City
Belfort
ZIP/Postal Code
90016
Country
France
Facility Name
APHP - CHU Avicenne - Oncologie Medicale
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Centre F. Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU - Pneumologie
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU Grenoble - pneumologie
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
APHP - Saint-Antoine - pneumologie
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
APHP - Hopital Tenon - Pneumologie
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
Saint-priest En Jarez
ZIP/Postal Code
42271
Country
France
Facility Name
CHU Lyautey - Pneumologie
City
Strasbourg
ZIP/Postal Code
63000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
16340839
Citation
Wislez M, Gounant V, Cadranel J. [Bronchioloalveolar carcinoma]. Rev Mal Respir. 2005 Dec;22(6 Pt 2):8S70-5. French.
Results Reference
background
PubMed Identifier
12796162
Citation
Wislez M, Massiani MA, Milleron B, Souidi A, Carette MF, Antoine M, Cadranel J. Clinical characteristics of pneumonic-type adenocarcinoma of the lung. Chest. 2003 Jun;123(6):1868-77. doi: 10.1378/chest.123.6.1868.
Results Reference
background
PubMed Identifier
26381515
Citation
Cadranel J, Gervais R, Merle P, Moro-Sibilot D, Westeel V, Bigay-Game L, Quoix E, Friard S, Barlesi F, Lethrosne C, Moreau L, Monnet I, Salaun M, Oliviero G, Souquet PJ, Antoine M, Langlais A, Morin F, Wislez M, Zalcman G; Intergroupe Francophone de Cancerologie Thoracique (IFCT). Erlotinib versus carboplatin and paclitaxel in advanced lepidic adenocarcinoma: IFCT-0504. Eur Respir J. 2015 Nov;46(5):1440-50. doi: 10.1183/13993003.02358-2014. Epub 2015 Sep 17.
Results Reference
derived
Links:
URL
http://www.ifct.fr
Description
Official French Intergroup website
Learn more about this trial
Therapeutic Strategy in Advanced Bronchioloalveolar Carcinoma
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